N/A
N=2,541
Pragmatic Investigation of optimaL Oxygen Targets Trial
Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT03537937 ↗Enrolled (actual)
2,541
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Ventilator-free Days (VFDs) to Study Day 28 — 20; 21; 21 number of days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lower SpO2 Target (Other); Intermediate SpO2 Target (Other); Higher SpO2 Target (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ventilator-free Days (VFDs) to Study Day 28 |
20; 21; 21 | — |
| SECONDARY 28-day, In-hospital Mortality (Secondary Outcome) |
281; 292; 290 | — |
| SECONDARY Intensive Care Unit Mortality (Exploratory Clinical Outcome) |
244; 259; 249 | — |
| SECONDARY Vasopressor-free Days (Exploratory Clinical Outcome) |
25; 25; 25 | — |
| SECONDARY Renal Replacement Therapy-free Days (Exploratory Clinical Outcome) |
28; 28; 0 | — |
| SECONDARY Intensive Care Unit-free Days (Exploratory Clinical Outcome) |
20; 19; 20 | — |
| SECONDARY Hospital-free Days (Exploratory Clinical Outcome) |
10; 10; 10 | — |
| SECONDARY Acute Kidney Injury (AKI) (Exploratory Organ Function Outcome) |
230; 253; 251 | — |
Summary
Mechanical ventilation of ICU patients universally involves titration of the fraction of inspired oxygen (FiO2) to maintain arterial oxygen saturation (SpO2). Despite decades of ICU practice, however, the optimal SpO2 target remains unknown. Current guidelines offer divergent recommendations as to the optimal SpO2 target. Therefore, we propose a 2,250-patient cluster-randomized cluster-crossover trial comparing a lower SpO2 target (90%; range 88-92%), an intermediate SpO2 target (94%; range 92-96%), and a higher SpO2 target (98%; range 96-100%) with regard to the outcome of days alive and free of invasive mechanical ventilation.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Receiving mechanical ventilation through an endotracheal tube or tracheostomy
- Admitted to the study ICU or admission to the study ICU from the emergency department is planned
Exclusion Criteria
- Known pregnancy or beta hCG level greater than the laboratory upper limit of normal in a patient capable of becoming pregnant
- Known to be a prisoner
Data sourced from ClinicalTrials.gov (NCT03537937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.